Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.
Eligibility criteria
Qualifiers
English speaking adults aged 18 and above.
diagnosis of opioid use disorder.
Self-reporting use of illicit opioids in >21 days in the prior 30 days.
Provide urine toxicology testing positive for fentanyl at baseline.
Disqualifiers
Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
Received buprenorphine or methadone treatment in prior 30 days.
Current diagnosis of alcohol or sedative/hypnotic use disorder.
Positive urine drug screen for benzodiazepines, alcohol and or methadone.
Trial design
Treatments tested in this trial
- Extended-release Buprenorphine
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
University of Utah
Collaborator
Source ClinicalTrials.gov